BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN

    MDR report key: 7041355 · Received November 17, 2017

    Report

    Report Number
    2210968-2017-71303
    Event Type
    Injury
    Date Received
    November 17, 2017
    Report Date
    October 20, 2017
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K032420
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. CITATION: J GASTROINTEST SURG (2011) 15:915¿921. DOI 10.1007/S11605-011-1490-1.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE THAT PATIENT UNDERWENT CURATIVE INTENT RESECTION PROCEDURE ON UNKNOWN DATE BETWEEN 10/2007 AND 10/2009 AND SUTURE WAS USED TO CLOSE THE ESOPHAGEAL ANASTOMOSIS WITH INTERMITTENT TECHNIQUE. THE PATIENT POSSIBLY DEVELOPED ANASTOMOTIC LEAK, DIAPHRAGMATIC HERNIA, LARYNGEAL NERVE PARALYSIS, WOUND INFECTION, PULMONARY INFECTION, DYSPHAGIA, AND / OR ANASTOMOTIC STRICTURE. AN ADDITIONAL PROCEDURE WAS INDICATED WITH A BALLOON TO DILATE POSTOPERATIVE ANASTOMOTIC STRICTURE. ADDITIONAL INFORMATION WILL BE REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    820156 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention